Engineer, NPI Manufacturing

Responsibilities

• Lead NPI manufacturing engineering activities, including process development, equipment readiness, and validation to ensure seamless product transitions.
• Collaborate with Product Development teams to provide DFM/DFA input, ensuring designs are robust, manufacturable, and scalable.
• Drive New Product Introduction (NPI) activities such as prototype builds, process trials, risk assessment, and production handover.
• Troubleshoot and resolve manufacturing, process, and equipment issues to improve yield and reduce downtime.
• Establish and maintain production procedures, work instructions, SOPs, and controlled manufacturing documentation.
• Execute and document process validation activities, including protocol preparation, trial execution, and data review.
• Drive continuous improvement initiatives using Lean and Six Sigma methodologies to optimize cost, yield, and efficiency.
• Ensure strict compliance with Quality, GMP, regulatory, and Occupational Health & Safety (OHS) standards.

Requirements

• Bachelor's Degree in Engineering (Mechanical, Manufacturing, Industrial, Mechatronics, or related field).
• Minimum 5 years of experience in manufacturing engineering, NPI engineering, or process engineering.
• Strong understanding of manufacturing processes, process validation, production systems, and equipment readiness.
• Proven experience in troubleshooting technical and manufacturability issues using structured problem-solving methods.
• Familiarity with GMP, quality systems, regulatory expectations, and documentation control.

Preferred Qualifications

• Experience in medical device, healthcare, or other highly regulated manufacturing environments.
• Certification or hands-on experience with Lean Manufacturing or Six Sigma methodologies.
• Strong exposure to design transfer, prototype builds, and process scale-up.
• Experience in project management or technical leadership within cross-functional environments.

About the Company

ResMed creates life-changing health technologies that empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions and cloud-connected devices make home healthcare more personalized, accessible, and effective.